PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

Constipation Clinical Trial

Official title:

PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153114
• Other study ID #: 851-15
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: February 6, 2013
• Start date: January 2003

Study information

• Verified date: February 2013
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: September 2004
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

Inclusion Criteria:

• Male or female outpatients between the ages of 4 to 16 years.

• Adolescent female patients must not be pregnant or lactating.

• constipated according to ROME I definition

• Two or fewer bowel movements during the initial observation week.

• Absence of a stool impaction

• Bowel movement after receiving enema

• Are otherwise in good health, as judged by a physical examination.

• Parent or guardian is mentally competent to sign an instrument of informed consent

Exclusion Criteria:

• Patients with heme positive stool at baseline exam.

• Patients with fecal impaction at baseline, or after the observation period, as indicated by physical exam

• Patients with known or suspected perforation or obstruction other than fecal impaction.

• Patients who are breastfeeding, pregnant or intend to become pregnant during the study.

• Female patients of childbearing potential who refuse a pregnancy test.

• Patients with a known history of organic cause for their constipation.

• Patients with congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases).

• History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.

• Use of concomitant medications that cause constipation

• Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.

• Patients with known allergy to polyethyleneglycol or polyethyleneglycol containing medications.

• Patients with clinically significant elevations of TSH or abnormal plasma electrolytes.

• Patients who, within the past 30 days have participated in an investigational clinical study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• polyethyleneglycol3350

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Greater than 2 bowel movements per week
Secondary	Analysis of individual ROME I criteria
Secondary	Safety (adverse event and laboratory testing)